Letter to Senator Biden and Senator Lugar on treatment targets in the new PEPFAR legislation Background below letter July 17, 2008   The Honorable Joseph Biden U.S. Senate 201 Russell Senate Office Building Washington, DC 20510-0802 The Honorable Richard Lugar U.S. Senate 306 Senate Hart Office Building Washington, DC 20510-1501   Dear Senators Biden and Lugar: Congratulations on passing a historic global health bill with such strong bipartisan support; millions of lives will be saved as a result of your hard work. Your teams worked heroically and found viable compromises to keep the bill moving over the numerous obstructions placed in our way. That is why we want to draw your attention to an issue of great concern regarding the compromise reached on treatment goals. We believe that the final language is unnecessarily vague and may have unintended consequences as a result. In the absence of a hard minimum target number of people on treatment, funding levels will drive program goals, rather than program goals determining needed funding. Without a clear treatment target to meet, appropriators and Budget Committee members will face increased challenges to preserve the continued trajectory of spending for AIDS treatment, especially at a time of economic contraction when other worthy issues also need attention. The original Senate bill language set a target of supporting treatment for three million people through bilateral programs plus additional numbers on treatment through multilateral programs such as the Global Fund to fight AIDS, Tuberculosis and Malaria (GFATM). Assuming the US continues its support for one-third of the GFATM’s budget, the original Senate bill would have supported treatment for four million people with US resources. Clarifying the intent of the Senate to treat at least three million people with HIV through bilateral programs will continue the momentum since 2003 to support treatment for one-third of those estimated to be in clinical need worldwide, and represent a serious effort to work towards universal access as pledged. That is why we believe that the bilateral treatment goal should be to treat three million people through bilateral programs. The lack of a hard minimum target and a complex and unpredictable formula makes progress difficult towards the Biden/Lugar/Coburn agreement to get more people on treatment. We respectfully request that the Report that accompanies the Senate bill include language to clarify that the intent is in fact to treat a minimum of 3 million with bilateral programs. We submit language below to establish the three million bilateral target as a floor, with the new formula applying if/when it would raise above that level. This will protect against the formula reducing the numbers on treatment, preserve the ability of programmers to plan towards a stable minimum target, and preserve the formula’s stated intent to increase the numbers on treatment. Acknowledging that no amendments can be included to the bill at this time, we request the following clarification be included in eventual appropriations report language. Additionally, we request a colloquy on the House Floor to clarify that we intend to treat at least three million through bilateral programs. The text below is in the form of an amendment, and only serves as one example to address the issue we are raising: Page 74, policy objectives of the United States to assist countries to, by 2013 to support— "(I) the increase in the number of individuals with HIV/AIDS receiving antiretroviral treatment above [at least 3,000,000 by 2013 or more, plus any additional pursuant to] the goal established under section 402(a)(3) and increased pursuant to paragraphs (1) through (3) of section 403(d); and "(II) additional treatment through coordinated multilateral efforts; The formula is on page 134: 403(d)(1) "(1) the [bilateral] treatment goal under section 402(a)(3) shall be increased above 2,000,000 by at least [the greater of 3,000,000 or] the percentage increase in the amount appropriated for bilateral global HIV/AIDS assistance for such fiscal year compared with fiscal year 2008; Thanks you for all of your work on this landmark bill. We look forward to continuing to work with you to ensure that the reauthorization of PEPFAR produces the best legislation possible. Sincerely,   ACT UP East Bay, CA ACT UP New York, NY ACT UP Philadelphia, PA African Services Committee, NY AIDS Community Research Initiative of America, USA AIDS Foundation Chicago, IL American Jewish World Service, USA American Medical Students Association (AMSA), USA American Public Health Association, International Health Section, USA CPATH (Center for Center for Policy Analysis on Trade and Health), USA GALAEI (Gay and Lesbian Latino AIDS Education Initiative), PA Global Action for Children, USA Global AIDS Alliance, USA Health Equity Project, USA Health GAP (Global Access Project), USA HIVictorious, Inc, WI Housing Works, NY International Center for Research on Women (ICRW), Int’l Intersect Worldwide, Int’l National Association of PLHAs in Nepal National Physicians Alliance, USA New York City AIDS Housing Network (NYCAHN), NY Physicians for Human Rights, USA Presbyterian Church, USA Priority Africa Network, CA RESULTS, USA Student Global AIDS Campaign, USA TII CAAN (Title II Community AIDS National Network), USA Treatment Action Group, USA Unitarian Universalist Association of Congregations, USA United Methodist Church, General Board of Church and Society, USA Background Senate PEPFAR 2 Treatment Formula: Unintended Consequences Could Slow Scale-Up 17 July 2008 In successful and heated negotiations surrounding the efforts to pass this landmark bill on global AIDS, TB and malaria, Senator Coburn was able to remove an ambitious AIDS treatment target. Inserted in its place is a formula that may have negative implications for people with AIDS. Under the new scheme, funding levels will drive program goals, rather than clear program goals necessitating funding. This translates into confusion for implementing agencies and future Global AIDS Coordinators who must now revise plans and targets on an annual basis to attempt to meet shifting and unpredictable policy goals based on undefined criteria. Most importantly, by linking treatment goals to annual appropriations levels and to treatment costs, the Coburn proposal creates financial incentives to treat fewer people with AIDS worldwide and/or to promote the use of outmoded toxic therapies instead of moving towards powerful but more expensive new generations of anti-AIDS medicines. This was not the intent of the bill, and needs to be clarified. Pre-Coburn Senate bill would have treated four million people The original Senate bill language set a target of supporting treatment for three million people through bilateral programs plus additional people with HIV treated through multilateral programs such as the Global Fund to fight AIDS, Tuberculosis and Malaria (GFATM). This was a very significant revision over the House bill that does not prohibit the current OGAC practice of counting sometimes very large percentages of the people treated by the GFATM towards the overall US targets. If the US continues to contribute at least 1/3rd of the funds for the GFATM, then the total number of people with AIDS receiving ARVs due to US action would have been at least four million individuals or more under the earlier Senate formulation. Treatment for four million people with HIV continues the momentum since 2003 to support treatment for one-third of those in clinical need worldwide, and represents a serious effort to work towards universal access as pledged. Undefined and Unpredictable Variables The Coburn formula now sets a floor of only two million on ARVs -- the five-year PEPFAR I goal intended to be reached by the end of this year. Every additional person on treatment is determined by a complex and unpredictable annual calculation that depends on the percentage increase of global AIDS-specific (not TB or malaria) appropriations above FY08 levels, as well as the unit cost of treatment. What is counted as “AIDS spending” is not defined. For example, will substantial health systems expenditures included in the legislation be measured as an increase in AIDS funding? Problems for Implementers The stable goal of supporting treatment for two million people over the first five years of PEPFAR programming allowed OGAC and implementing agencies to collaborate with each other, country-partners and other donor agencies continuously and make steady progress towards meeting this target. The difficulty of implementers and OGAC to program towards an uncertain and shifting treatment goal will create incoherence at the country level, and reduce ambition on the part of program partners and administrators. Disincentive for Treatment Scale-up The formula reverses the annual appropriations equation by removing the signature hallmark policy of PEPFAR’s first five years. In place of a hard target that can be measured and costed on an annual basis, the new scheme may be a disincentive to increase the numbers of people with HIV on treatment. Without a clear treatment target to meet, appropriators and Budget Committee members will face increased challenges to preserve the needed upward trajectory of spending for AIDS treatment, especially at a time of economic contraction when other worthy issues also need attention. This is doubly true considering uncertainty about the level of presidential support in the next round of US foreign assistance appropriations. Treatment Costs Rise Another variable in the Senate bill is an annual adjustment to potentially increase the treatment goal in an undefined manner based on decreases in unit costs of treatment. Although this appears as responsive to decreases in costs resulting from increased generic competition, the reality over the next five years is that significant (if temporary) increases in treatment costs per patient are almost certain. The reason is that the developing world is moving gradually towards the very powerful new drug regimens that are already utterly transforming AIDS therapy in the United States. New medicines and improved standards of care over the last two years and in the near future have finally made HIV/AIDS a chronic manageable illness in wealthier countries. This makes obsolete the less effective, less durable, and less tolerable therapies with high toxicity-profiles still common in impoverished countries. It can take several years for generic producers to bring down the costs of new medicines. In the mean time, higher per-patient costs must be expected. Nonetheless, the move towards dramatically improved new medicines must be an urgent priority, especially when measured against the health and diplomacy costs of continuing to use medicines (like D4T) that are being phased out in the United States. The only way that funding formula could increase the numbers on treatment is if the US were to continue to promote increasingly obsolete drug regimens to impoverished countries -- not a tenable option. Proposal: Safeguard 3 Million Treatment Target as a Minimum Establish three million plus GFATM as a floor, with the new formula applying above that level. This will protect against the formulation reducing the numbers on treatment, preserve the ability of programmers to plan, and enable the formula’s stated intent to increase the numbers on treatment. Acknowledging that no amendments can be included to the bill at this time, we request the following clarification be included in eventual appropriations report language. Additionally, we request a colloquy on the House Floor to clarify that we intend to treat at least three million through bilateral programs. The text below is in the form of an amendment, and only serves as one example to address the issue we are raising: Page 74, policy objectives of the United States to assist countries to, by 2013 to support— "(I) the increase in the number of individuals with HIV/AIDS receiving antiretroviral treatment above [at least 3,000,000 by 2013 or more, plus any additional pursuant to] the goal established under section 402(a)(3) and increased pursuant to paragraphs (1) through (3) of section 403(d); and "(II) additional treatment through coordinated multilateral efforts; The formula is on page 134: 403(d)(1) "(1) the [bilateral] treatment goal under section 402(a)(3) shall be increased above 2,000,000 by at least [the greater of 3,000,000 or] the percentage increase in the amount appropriated for bilateral global HIV/AIDS assistance for such fiscal year compared with fiscal year 2008;